Short Post-surgical Antibiotic Therapy in Spine Infections - a Prospective, Randomized, Unblinded, Non-inferiority Trial

Sponsor

Balgrist University Hospital (Other)

Overall Status

Recruiting

CT.gov ID

NCT04048304

Collaborator

(none)

236

Enrollment

Location

Arms

Anticipated Duration (Months)

5.8

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

We implement a prospective, randomized, unblinded, non-inferiority trial regarding the duration of systemic, targeted antibiotic therapy after the first surgical debridement for spine infection; randomizing 1:1 between

Six and twelve weeks of antibiotic therapy if there is an implant left in place
Three and six weeks of antibiotic therapy if there is no implant left

Condition or Disease	Intervention/Treatment	Phase
Infection	Drug: duration of standard antibiotic therapy	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

236 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

1:1 randomization1:1 randomization

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Short Post-surgical Antibiotic Therapy in Spine Infections - a Pro-spective, Randomized, Unblinded, Non-inferiority Trial

Actual Study Start Date :

Jul 31, 2019

Anticipated Primary Completion Date :

Dec 31, 2022

Anticipated Study Completion Date :

Dec 31, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: short antibiotic therapy 3 weeks of antibiotic therapy with no implant left in place 6 weeks of antibiotic therapy with implant left in place	Drug: duration of standard antibiotic therapy antibiotic therapy for spine infections. 3 vs 6 weeks if no implant left in place. 6 vs 12 weeks if implant left in place. The antibiotic agents used are officially indicated for orthopedic infections, including spine infections and available in Switzerland since decades. Standard dosing will be applied and only modified according to the patient's co-morbidities, intolerances and weight. Other Names: Co-amoxiclav, vancomycin
Active Comparator: long antibiotic therapy 6 weeks of antibiotic therapy with no implant in place 12 weeks of antibiotic therapy with implant left in place	Drug: duration of standard antibiotic therapy antibiotic therapy for spine infections. 3 vs 6 weeks if no implant left in place. 6 vs 12 weeks if implant left in place. The antibiotic agents used are officially indicated for orthopedic infections, including spine infections and available in Switzerland since decades. Standard dosing will be applied and only modified according to the patient's co-morbidities, intolerances and weight. Other Names: Co-amoxiclav, vancomycin

Arm

Intervention/Treatment

Experimental: short antibiotic therapy

3 weeks of antibiotic therapy with no implant left in place 6 weeks of antibiotic therapy with implant left in place

Drug: duration of standard antibiotic therapy

antibiotic therapy for spine infections. 3 vs 6 weeks if no implant left in place. 6 vs 12 weeks if implant left in place. The antibiotic agents used are officially indicated for orthopedic infections, including spine infections and available in Switzerland since decades. Standard dosing will be applied and only modified according to the patient's co-morbidities, intolerances and weight.

Other Names:

Co-amoxiclav, vancomycin

Active Comparator: long antibiotic therapy

6 weeks of antibiotic therapy with no implant in place 12 weeks of antibiotic therapy with implant left in place

Drug: duration of standard antibiotic therapy

Other Names:

Co-amoxiclav, vancomycin

Outcome Measures

Primary Outcome Measures

Remission of infection at 12 months after treatment [12 months after treatment]
no clinical and microbiological recurrences

Secondary Outcome Measures

costs [up to 12 months]
total costs for treatment of infection
duration of sick leave [up to 12 months]
duration of sick leave for treatment of infection
length of hospital stay [up to 12 months]
number of days of hospital stay

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Spine surgery and intraoperative debridement with any technique
At least 12 months of scheduled follow-up from hospitalization
Bacterial spine infection of any nature, independently of implants or co-morbidities

Exclusion Criteria:

Mycobacterial, fungal, nocardial, and Actinomyces infections in the spine
Non-resected cancer in the infection site
Bone marrow or recent solid organ transplant patient (Recent: <5 years)
Any other infection in the patient requiring more than 6 weeks of antibiotic therapy
More than three intraoperative debridements performed for spine infection
Absence of at least one surgical intraoperative debridement of infection

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Balgrist University Hospital	Zürich	Zurich	Switzerland	8008

Sponsors and Collaborators

Balgrist University Hospital

Investigators

Study Director: Ilker Uckay, PD Dr med, Balgrist University Hospital

Study Documents (Full-Text)

Statistical Analysis Plan - May 24, 2022

More Information

Publications

None provided.

Responsible Party:

Balgrist University Hospital

ClinicalTrials.gov Identifier:

NCT04048304

Other Study ID Numbers:

SASI

First Posted:

Aug 7, 2019

Last Update Posted:

Jul 7, 2022

Last Verified:

Jul 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Infections

Communicable Diseases

Anti-Bacterial Agents

Vancomycin

Study Results

No Results Posted as of Jul 7, 2022